五种中药制剂微生物限度检查方法的建立和验证

Establishment and Validation of Microbial Limit Test Method for Five Kinds of Traditional Chinese Medicine Preparation

目的:建立5种中药制剂的微生物限度检查方法。方法:按照《中国药典》2010年版的规定测定各品种对5个规定试验菌株的回收率,并对其控制菌检查方法进行验证。结果:补气益肾颗粒、补气健脾丸均无明显的抑菌作用;麻白止咳颗粒、解毒宣肺丸、活血通痹丸均有不同程度的抑菌作用,但可通过培养基稀释法消除抑菌作用。结论:补气益肾颗粒、补气健脾丸按常规法进行细菌数的检查;麻白止咳颗粒、解毒宣肺丸、活血通痹丸用培养基稀释法进行细菌数的检查;以上5种药品的霉菌及酵母菌总数的检查按平皿法;控制菌检查按常规法进行。

Objective： To establish the methods of microbial limit test for five kinds of traditional Chinese medicine preparation. Methods： The recovery rates of five stipulated microorganisms treated respectively by five kinds of Traditional Chinese medicine preparation were detected according to Chinese Pharmacopoeia 2010, and the microbial limit test methods for the specific micro organisms were validated. Results： Buqiyishen granules, Buqijianpi pills didnlt show significant antibacterial activity. Mabaizhike granules, Jieduxuanfei pills, Huoxuetong- bi pills had antimicrobial effect, and the effect can be eliminated by culture medium dilution method. Conclusions： The common method can be used for the microbial limit test of Buqiyishen granules and Buqijianpi pills. The dilution method can be used for the microbial limit test of Mabaizhike granules, Jieduxuanfei pills and Huoxuetongbi pills. The plate method can be used for test of the number of molds and yeasts of five kinds of drugs. The common method is suitable for all kinds of specified microorganisms.